Quality Assurance Specialist

2 weeks ago


Addlestone, Surrey, United Kingdom Astellas Europe Full time

About Astellas Europe

Astellas Europe is a progressive health partner delivering value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential and developing solutions for patients with high unmet needs.

As the QA Affiliate, you will independently complete standard quality assurance activities in the affiliate, supporting the Responsible Person Import (RPi) and the QA Lead to meet their responsibilities and accountabilities.

The role involves performing and processing activities governed by Good Distribution Practice Guidelines (GDP Guidelines), as defined in the global Quality Management System. This includes QA oversight of product storage and distribution, nonconformance management, product complaint handling, change control, supplier management, and annual product review.

The estimated salary for this position is around €50,000 - €60,000 per year, depending on location and experience.

Key Responsibilities:

  • Perform and process activities governed by GDP Guidelines
  • Implement improvements to correct inefficiencies and non-conformances
  • Support inspection management for the wholesale dealer license
  • Represent Affiliate QA in project teams and act as a role model for Quality Culture

Essential Knowledge & Experience:

  • Relevant transferable skills in a comparable role in the pharmaceutical industry
  • Understanding of implementation and understanding of GDP, GMP, and Quality Management Systems
  • Good organizational, coordination, presentation, and communications skills

Benefits:

  • Hybrid working solution allowing time to connect with colleagues and work from home
  • Opportunity to work with a progressive health partner delivering value and outcomes
  • Role requires a blend of home and minimum 1 day per week in our local office


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